This website is dedicated to providing public information regarding DePuy Hip recall and other related information to the recall. None of the information on this site is intended to be formal legal or medical advice, nor should any information on this site be construed as advice that should be used in lieu of information from your attorney or physician.

Thursday, January 24, 2013

Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

Action

Proposed Order.

Summary

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements